BioDelivery Sciences International, Inc. (BDSI) and Teva Pharmaceuticals USA, Inc. engaged in patent litigation centered on BDSI’s branded opioid addiction and pain management products, BELBUCA® (buprenorphine) and BUNAVAIL® (buprenorphine/naloxone). The dispute arose after Teva filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval for generic versions of these drugs. Below is a summary of the key litigation milestones and outcomes:
Case Overview
Case Name: BioDelivery Sciences International, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al.
Docket No.: 1:17-cv-00118 (D. Del.)
Filed: February 3, 2017
Judges: Gregory M. Sleet and Maryellen Noreika
Claims: Patent infringement under 35 U.S.C. § 271(e)(2) (BELBUCA® patents) [1][7].
Key Developments
-
BELBUCA® Litigation (2017–2018)
- BDSI alleged Teva’s generic buprenorphine film infringed two U.S. patents covering BELBUCA®’s formulation and delivery mechanism [2][7].
- Settlement (February 2018):
- Teva agreed to delay launching its generic until January 23, 2027 (or earlier under undisclosed conditions) [2].
- Terms included a non-exclusive license for Teva and confidentiality, pending FTC/DOJ review [2].
- BDSI noted the settlement preserved capital by avoiding litigation costs and secured patent exclusivity [2].
-
BUNAVAIL® Settlement (2017)
- A parallel lawsuit over BUNAVAIL® (Case No. 1:17-cv-00119) settled in October 2017, allowing Teva’s generic entry on July 23, 2028 [3].
Strategic Implications
- Market Exclusivity: The settlements extended BDSI’s revenue runway for its branded products until at least 2027–2028.
- Portfolio Defense: BDSI’s litigation strategy emphasized protecting its core pain management IP while avoiding protracted legal battles [2][3].
- Teva’s Generic Pipeline: The agreements aligned with Teva’s broader efforts to challenge branded drug patents, leveraging ANDA filings to secure future market entry dates [2][3][10].
Brother Case (2016)
A related 2016 complaint (BioDelivery Sciences et al. v. Teva, C.A. No. 16-1392) in Delaware addressed similar patent claims for BELBUCA®, underscoring BDSI’s proactive enforcement against Teva’s ANDA submissions [7].
Analysis
- Patent Staleness Risk: BDSI’s patents faced validity challenges typical in Hatch-Waxman litigation, but early settlements mitigated uncertainty [2][3].
- Regulatory Hurdles: Both settlements required antitrust reviews, reflecting heightened scrutiny of “pay-for-delay” pharma agreements [2][3].
- Industry Trend: The cases exemplify how mid-sized pharma firms leverage litigation to delay generics, balancing IP protection with cost containment.
This litigation underscores the high stakes of pharmaceutical patent disputes, where settlements often prioritize commercial certainty over judicial outcomes. BDSI’s dual resolutions with Teva illustrate a pragmatic approach to safeguarding revenue streams while managing litigation risk.
References
- https://unicourt.com/case/pc-db1-biodelivery-sciences-international-inc-et-al-v-teva-pharmaceuticals-usa-inc-et-al-388533?init_S=csup_ltst
- https://www.globenewswire.com/news-release/2018/02/06/1333512/0/en/BioDelivery-Sciences-Announces-BELBUCA-Patent-Litigation-Settlement-Agreement-with-Teva.html
- https://www.biospace.com/biodelivery-announces-patent-litigation-settlement-agreement-with-teva
- https://www.supremecourt.gov/DocketPDF/20/20-158/149882/20200824164214083_20200824-162424-00000478-00001567.pdf
- http://www.gbpatent.com/content/uploads/Post-Grant-filings.pdf
- https://www.govinfo.gov/content/pkg/USCOURTS-mad-1_18-cv-12029/pdf/USCOURTS-mad-1_18-cv-12029-0.pdf
- https://insight.rpxcorp.com/litigation_documents/12279347
- https://www.governmentattic.org/docs/FOIA_Logs_SEC_FY2006-07.pdf
- https://www.law.berkeley.edu/wp-content/uploads/2021/03/2020-11-25_20-3837_NEF17_AppellantFormC.pdf
- https://www.cafc.uscourts.gov/opinions-orders/24-1936.OPINION.12-20-2024_2439730.pdf
- https://www.juve-patent.com/cases/teva-and-pinsent-masons-invalidate-two-novartis-patents-for-exjade/
